While pricing a $67.8 million registered direct offering, Icosavax Inc. also released positive top-line interim data from a phase I study of IVX-A12 against respiratory syncytial virus (RSV) and human metapneumovirus in older adults.
Efficacy data for Pfizer Inc.’s respiratory syncytial virus (RSV) vaccine proved convincing for members of the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee, which voted 14-0 May 18 in favor of Abrysvo’s effectiveness when administered during the second or third trimester of pregnancy to protect infants from birth to 6 months, with the adcom endorsing safety data in a 10-4 vote.
The U.S. FDA has approved the country’s first-ever respiratory syncytial virus (RSV) vaccine, Arexvy, from GSK plc. The adjuvanted vaccine is also the first for older adults anywhere on the planet. GSK now has a head start to vaccinate the U.S. market, but other big companies, such as Sanofi SA and especially Pfizer Inc., are in late-stage development and will pose strong challenges in the coming year. Pfizer’s PF-0692831/RSVpreF, an RSV vaccine for treating lower respiratory tract disease caused by RSV, has a priority BLA with a May 31 PDUFA date.
Although the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously, 12-0, March 1 that the data GSK plc presented was adequate to support the safety of its respiratory syncytial virus vaccine, several panelists cautioned the FDA against viewing the vote as a recommendation to license the vaccine before more data are available.
Now there are three. Moderna Inc. has posted strong phase III study data on its mRNA respiratory syncytial virus (RSV) vaccine, keeping pace with Pfizer Inc. and GSK plc’s candidates, which have May PDUFA dates. Moderna’s top-line results of the ConquerRSV pivotal efficacy study of mRNA-1345 show the vaccine hit its primary efficacy endpoints of 83.7% against RSV-associated lower respiratory tract disease in older adults.
After comparing the response to the two types of vaccines for the respiratory syncytial virus (RSV) based on its fusion protein (F), prefusion (pre-F) versus postfusion (post-F) vaccines, scientists at the National Institutes of Health (NIH) and Astrazeneca plc have demonstrated that targeting the pre-F protein led to better protection. No more bets on RSV immunization based on the post-F protein of the virus. Laboratories can now bet all on red for the pre-F technology.
Poolbeg Pharma plc has identified potential new drug candidates from its respiratory syncytial virus (RSV) artificial intelligence (AI) program with Onethree Biotech Inc.
Pfizer Inc. has acquired rights to respiratory syncytial virus (RSV) drug candidate sisunatovir from Lianbio Co. Ltd. in a deal worth up to $155 million covering development and commercialization rights in mainland China, Hong Kong, Macau and Singapore. With this agreement, Pfizer now holds global development and commercialization rights to the candidate, an orally administered fusion inhibitor is designed to block RSV replication by inhibiting F-mediated fusion with the host cell.
Both neutralizing antibodies and antibody effector functions are needed for protection against re-infection with respiratory syncytial virus (RSV), which may explain why it has been challenging to design an effective vaccine against the virus. As reported in the Dec. 12, 2022, issue of Cell, researchers carried out a human challenge study where volunteers were given a candidate vaccine for RSV, Ad26, or placebo.
Atriva Therapeutics GmbH, a small firm founded in 2015 to develop a host-targeted antiviral approach for treating respiratory viral infections, seems to have found itself in thick of it. As the U.S. CDC and other health agencies warn of an uptick in respiratory viral infections – the so-called “tripledemic” of influenza, respiratory syncytial virus and COVID-19 – the German company is gearing up to launch a basket trial testing lead candidate zapnometinib in all three indications.
